On January 10, 2007, Davol, Inc. sent letters to health care professionals and distributors telling them to stop using the recalled product, specific lots of Bard Composix Kugel Large Oval and Large Circle Mesh Patches, and return unused units to the company.
The “memory recoil ring” that opens the Bard Composix Kugel Mesh Patch can break under the stress of placement of the large sized products inside the belly area space. This can lead to bowel perforations (rupture) and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms. People often overlook these symptoms, but they can indeed be very serious.
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